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    Public Citizen, FDA Advisor Call for Moratorium on Opioid Approvals

    Nonprofit advocacy group Public Citizen on Thursday filed a citizen petition calling for the US Food and Drug Administration (FDA) to impose a moratorium on approving new or reformulated opioids until the agency implements recommendations from a 2017 report by the National Academies of Science, Engineering and Medicine.   The petition is undersigned by Raeford Brown, the chair of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee who has spoken out again...
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    Reorganization of FDA’s Office of the Commissioner to Begin Soon

    Beginning 31 March, the US Food and Drug Administration’s (FDA) Office of the Commissioner will reorganize and make several changes to various offices within FDA, including the Office of New Drugs (OND). With an eye toward efficiency and better connecting the Office of the Commissioner with center directors and other office leadership, outgoing FDA Commissioner Scott Gottlieb said in an email to staff on Thursday that the reorganization plan “elevates the role of the Ce...
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    FDA’s OCP Works to Modernize Review Functions

    Modernized regulatory review functions for drugs and biologics applications were implemented at the US Food and Drug Administration’s (FDA) Office of Clinical Pharmacology (OCP) in 2018 and will be used to prepare for 2019 priority areas related to the opioid crisis, antimicrobial resistance and rare diseases. OCP, within the Center for Drug Evaluation and Research (CDER), outlined newly implemented steps for modernizing review functions in its recently released annual ...
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    EU Regulatory Roundup: Denmark Teams With WHO to Help Build Regulatory Capacity in Poorer Countries

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Government Holds off Backlash Against ‘Extraordinary Power Grab’ on Drug Shortages   The United Kingdom government has resisted an attempt to revoke changes to the handling of drug shortages. An opposition politician called the serious shortage protocol reforms an “extraordinary power grab” but was unable to rally enough support in parliament to get the changes r...
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    To Prevent Losartan Shortages, FDA Allows Higher Impurity Levels

    To ensure patient access to the blood pressure medicine losartan, the US Food and Drug Administration (FDA) said late Wednesday that it will not object to certain manufacturers temporarily distributing losartan with one impurity above the interim acceptable intake limit until that impurity can be eliminated. For such companies, losartan “containing N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the  interim acceptable intake limit  of 0.96 parts per million (ppm) a...
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    UK Offers More No-Deal Brexit Guidance on Clinical Trials, PIPs

    With a glimmer of hope for a short extension to the Brexit deadline of 29 March, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is still releasing guidance in case Brexit occurs without a deal in place. On Wednesday, the MHRA published guidance on registering clinical trials, publishing trial results, future trial transparency efforts and the process for applicants applying for a Pediatric Investigation Plan (PIP), waiver, deferral or product-specif...
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    EMA Follows FDA Warning on Xeljanz Blood Clot Risks

    The European Medicines Agency (EMA) on Wednesday warned patients and healthcare professionals against exceeding the recommended dose of Pfizer’s rheumatoid arthritis (RA) drug Xeljanz (tofacitinib) due to an increased risk of blood clots forming in the lungs.   EMA’s warning comes less than a month after the US Food and Drug Administration (FDA) issued a similar warning after identifying the risk during an ongoing postmarketing safety study for the drug. In the lat...
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    Breast Implant Manufacturers Draw FDA Warning Letters Over Post-Approval Studies

    The US Food and Drug Administration (FDA) sent warning letters this week to two breast implant manufacturers over their failures to comply with FDA’s post-approval study (PAS) requirements. The warning letters were made public by FDA late Tuesday and sent to Sientra and Mentor Worldwide on Monday for being in violation of two of the seven requirements established as part of their devices’ conditional approvals. They underscore an emerging FDA enforcement trend around PA...
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    OMB Reviews Proposal to Add Prices to Pharma TV Ads

    The Office of Management and Budget (OMB) this week began reviewing a proposed rule that would require drug companies to include list prices in direct-to-consumer television advertisements. The rulemaking, now one step closer to finalization in some form, was released by the Centers for Medicare and Medicaid Services (CMS) last October and seeks to further shine a spotlight on drug and biologic prices, with the hope of reducing prices in the process. HHS Secretar...
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    IMDRF Explains How to Build Submissions Using its Table of Contents Structure

    The International Medical Device Regulators Forum (IMDRF) issued a final assembly and technical guide on building submissions using the IMDRF Table of Contents (ToC) structure, including harmonized technical guidelines on the acceptable folder structure and file format(s) for ToC-based submissions. The final guide was posted on Wednesday after IMDRF convened in Moscow—Russian regulators are currently chairing IMDRF—for a three-day open stakeholders forum that kicked off...
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    EU Publishes First Corrigenda for MDR, IVDR

    As part of an effort to fix the mistakes, inconsistencies and slightly correct the EU’s Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR), the Council of the European Union this week released two corrigenda. Although the documents do not alter the transition deadlines for companies (some had hoped there might be a break for struggling class I device companies), the corrigenda do offer a look into areas of the regulations where there may have been confusion...
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    WHO Panel Calls for Global Gene Editing Registry

    The World Health Organization’s (WHO) newly-formed advisory panel on human genome editing is calling for the creation of a central registry for all human genome editing studies following a two-day meeting that concluded in Geneva on Tuesday.   WHO established the panel in December following reports that Chinese scientist He Jiankui had modified the genomes of a pair of twin girls to make them resistant to HIV infection. Jiankui’s claims prompted swift international b...